DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 26 June 2026.
Notice of AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
In the response filed 26 June 2026, Applicant amended the preamble of independent claims 1 and 12 to recite “a lumen apposing stent” rather than an implantable medical device.
Applicant argues Ben-Muvhar’169 is directed towards a “flow reducing implant” to reduce the amount of blood flowing through a vessel while a lumen apposing stent is to establish fluid communication between anatomical structures. Applicant argues BenMuvhar’169’s “flow reducing implant” is not analogous art to the claimed lumen apposing stent.
Examiner disagrees. MPEP 2141.01(a) states:
A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or
(2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention).
Ben-Muvhar’169 meets both requirements for analogous art:
The field of endeavor is not limited to the specific point of novelty, the narrowest possible conception of the field, or the particular focus within a given field. Ben-Muvhar’169’s “flow reducing implant” is in the same field of endeavor as “lumen apposing stents” because both devices are medical implants configured to direct the flow a fluid within the body.
Ben-Muvhar’169 is reasonably pertinent to the problem faced by the inventor because they have a similar structure and are both in the field of medical implants. Specifically, both Applicant’s invention and Ben-Muvhar’169 device have distal and proximal retention members for maintaining the position in the implant withing the body and a lumen passing through the elongate body. Ben-Muvhar’169 and Applicant’s invention both include an anti-migration feature to maintain the position of the device within the body.
Applicant argues Shank’s implant with improved anchoring is not analogous to a lumen apposing stent. Again, Examiner maintains Shank’s anti-migration feature on a medical implant is reasonably pertinent to the problem faced by the inventor of maintaining the position of an implant within the body. Therefore, Shank is directed towards analogous art.
Further, MPEP 2114 Section II states “A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.”
In this case, Ben-Muvhar’169 in view of Shank’086 renders the claimed structure obvious. Apparatus claims cover what a device is, not what a device does. The resulting device is fully capable of functioning as a “lumen apposing stent” because it has the claimed structure, including a lumen extending through the elongate body.
For these reasons, the rejection was updated to address the claim amendments but is otherwise maintained.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9, 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Muvhar et al. (US Patent Publication 2016/0256169) in view of Shank et al. (US Patent Publication 2012/0179086).
Claim 1: Ben-Muvhar’169 teaches a lumen apposing stent (1200; Figure 7b; this is a “lumen apposing stent” because it has the features of the claimed apparatus, as outlined below – in particular, the elongate body defines a lumen passing through which will allow fluid to flow through therethrough) comprising:
an elongate body (Figure 7b) having a proximal end (towards the left side of the figure) and a distal end (towards the right side of the figure) and defining a lumen extending therethrough (Figure 3c shows the device 1200 mounted on a catheter which shows there is a lumen passing through it);
a proximal retention member (flared portion on the left side of Figure 7b; labeled as 202 in Figure 2) along the proximal end of the elongate body;
a distal retention member (flared portion on the right side of Figure 7b; labeled as 200 in Figure 2) along the distal end of the elongate body;
a saddle region (central, narrow region in Figure 7b; labeled as 204 in Figure 2) defined between the proximal retention member and the distal retention member (Figure 7b); and
at least one anti-migration feature (1202, 1204) extending longitudinally from a radially outer-most surface of at least one of the retention members (Figure 7b and paragraph [0165] describes 1202 and 1204 as extending parallel to the blood vessel and catch on tissue of the blood vessel; 1202, 1204 need to be on the radially outer most surface of the retention members to perform this function).
wherein:
at least the saddle region has a wall with a coating formed of a material preventing flow of fluid therethrough (paragraph [0022]); and
Ben-Muvhar’169 does not specifically disclose the anti-migration feature (1202, 1204) is uncoated to promote tissue ingrowth therearound or that the anti-migration feature extends into a closed shape defining an opening.
Like Ben-Muvhar’169, Shank’086 teaches an implantable medical device (100) for placement in a tubular body cavity and providing the implant (100) with anti-migration features (110) that extend longitudinally along the vessel (paragraph [0028]: “Alternatively, the loop 112 may be formed such that the face 122 is parallel to the long axis of the struts 124. In this alternative orientation, the face 122 is near parallel to the lumen's long axis and near perpendicular to the lumen's cross section when implanted.”) The anti-migration features have a closed shape (112) and define an opening (112 is a loop) so tissue grows through the opening and around the anti-migration feature (110) to resist migratory forces on the implantable medical device (paragraph [0029]). Shank’086 teaches the closed shape (112) is advantageous over barbs because they promote tissue ingrowth and do not provoke tissue remodeling which eventually forces other projections out of the body lumen (paragraph [0029]). Shank’086 further teaches leaving the anti-migration feature uncoated to promote tissue ingrowth (paragraph [0057]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Ben-Muvhar’169 such that the anti-migration feature is in a closed shape, as taught by Shank’086, in order to provide the above stated advantages.
Claim 2: Shank’086 teaches the anti-migration member (110) is in the form of a loop (112).
Claim 3: Shank’086 teaches the anti-migration member (110) includes at least one retention portion extending transverse to an axis along which migratory forces impact the implantable medical device (note: in the specification, the “retention portion” 152 is the tip of the loop 150; Shank’086 also teaches a tip of a loop and this is considered the “retention portion”). The retention portion (tip of the loop 112) is transverse to an axis along which migratory forces impact the implantable medical device (Shank’086 and Ben-Muvhar’169 teach the anti-migration member is oriented in the same direction as applicant’s invention).
Claim 4: Ben-Muvhar’169 teaches the lumen of the elongate body extends through the saddle region (Figure 3c shows the device 1200 mounted on a catheter which shows there is a lumen passing through it).
In the device of modified Ben-Muvhar’169, the retention portion (tip of the loop 112) extends transverse to the longitudinal axis of the saddle region (both Ben-Muvhar’169 and Shank’086 disclose anti-migration members extend parallel with the vessel; therefore, their tips will be transverse to the longitudinal axis of the saddle region).
Claim 5: Ben-Muvhar’169 teaches the at least one anti-migration feature (1202) extends from the proximal retention member in a direction toward the saddle region (Figure 7b).
Claim 6: Ben-Muvhar’169 teaches the proximal retention member (flared portion on the left side of Figure 7b; labeled as 202 in Figure 2) and the distal retention member (flared portion on the right side of Figure 7b; labeled as 200 in Figure 2) extend radially outwardly from the saddle region (central, narrow region in Figure 7b; labeled as 204 in Figure 2) (see Figure 7b); and
the anti-migration feature (1202) extends from the proximal retention member and is transverse to the proximal retention member in a direction toward the saddle region (Figure 7b).
Claim 7: Ben-Muvhar’169’s saddle region (central, narrow region in Figure 7b; labeled as 204 in Figure 2) is configured to extend between a proximal tissue wall and a distal tissue wall (based on its size and shape and disclosed use for implantation within the body),
the proximal retention member (flared portion on the left side of Figure 7b; labeled as 202 in Figure 2) is configured to anchor the stent with respect to the proximal tissue wall (based on its size and shape and disclosed use for implantation within the body),
the distal retention member (flared portion on the right side of Figure 7b; labeled as 200 in Figure 2) is configured to anchor the stent with respect to the distal tissue wall (based on its size and shape and disclosed use for implantation within the body).
Shank’086 teaches the anti-migration feature (110) is configured to embed into the tissue wall (Figure 3a-3c; paragraph [0029]).
Claim 8: Ben-Muvhar’169 teaches the one anti-migration feature includes at least one anti-migration feature (1202) extending from the proximal retention member toward the saddle region (Figure 7b) and at least one anti-migration feature (1204) extending from the distal retention member toward the saddle region (Figure 7b).
Claim 9: Ben-Muvhar’169 teaches the lumen apposing stent (Figure 7b) is shiftable between an elongated delivery configuration and a foreshortened deployed configuration (paragraph [0133]);
the proximal retention member (202) and the distal retention member (200) are defined upon the stent shifting to the deployed configuration and a portion of the elongate body extending radially outward (Figure 3 shows the device in the collapsed configuration and the retention members are not defined; Figure 7b shows the device in the expanded configuration and the retention members are defined);
and in the foreshortened configuration, the length of the saddle region and the configuration of the proximal retention member and the distal retention member are selected to draw together tissues across which the elongate body is extended (this is directed towards the intended use of the device; the surgeon will choose the size of the implant based on the desired implant location. Ben-Muvhar’169’s saddle region inherently has a length and the proximal and distal retention members inherently have a configuration and the combination of these features, in some situation, will aid in drawing tissue together) with the at least one anti-migration feature anchoring into the tissues (1202, 1204; paragraph [0165]).
Claim 11: Shank’086 teaches the anti-migration feature (110) is separately formed from and coupled to the device (via a crimp 116).
Claim 12: Ben-Muvhar’169 teaches a lumen apposing stent (1200; Figure 7b) comprising:
an elongate body (Figure 7b) having a proximal end (towards the left side of the figure) and a distal end (towards the right side of the figure) and defining a lumen extending therethrough (Figure 3c shows the device 1200 mounted on a catheter which shows there is a lumen passing through it);
at least one anti-migration feature (1202, 1204) extending longitudinally from a radially outer-most surface of at least one of the retention members (Figure 7b and paragraph [0165] describes 1202 and 1204 as extending parallel to the blood vessel and catch on tissue of the blood vessel; 1202, 1204 need to be on the radially outer most surface of the retention members to perform this function);
wherein:
the elongate body (Figure 7b) is formed from a plurality of filaments forming a wall of the elongate body with interstices therethrough (paragraph [0140]);
at least a portion of the wall of the elongate body is coated to prevent flow of fluid therethrough and to resist tissue ingrowth (paragraph [0022]);
Ben-Muvhar’169 does not specifically disclose the anti-migration feature (1202, 1204) is uncoated to promote tissue ingrowth therearound or that the anti-migration feature extends into a closed shape defining an opening.
Like Ben-Muvhar’169, Shank’086 teaches an implantable medical device (100) for placement in a tubular body cavity and providing the implant (100) with anti-migration features (110) that extend longitudinally along the vessel (paragraph [0028]: Alternatively, the loop 112 may be formed such that the face 122 is parallel to the long axis of the struts 124. In this alternative orientation, the face 122 is near parallel to the lumen's long axis and near perpendicular to the lumen's cross section when implanted.) The anti-migration features have a closed shape (112) and define an opening (112 is a loop) so tissue grows through the opening and around the anti-migration feature (110) to resist migratory forces on the implantable medical device (paragraph [0029]). Shank’086 teaches the closed shape (112) is advantageous over barbs because they promote tissue ingrowth and do not provoke tissue remodeling which eventually forces other projections out of the body lumen (paragraph [0029]). Shank’086 further teaches leaving the anti-migration feature uncoated to promote tissue ingrowth (paragraph [0057]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Ben-Muvhar’169 such that the anti-migration feature is in a closed shape, as taught by Shank’086, to provide the above stated advantages.
Claim 13: Shank’086 teaches the anti-migration member (110) is in the form of a loop (112).
Claim 14: Shank’086 teaches the anti-migration member (110) includes at least one retention portion extending transverse to an axis along which migratory forces impact the implantable medical device (note: in the specification, the “retention portion” 152 is the tip of the loop 150; Shank’086 also teaches a tip of a loop and this is considered the “retention portion”). The retention portion (tip of the loop 112) is transverse to an axis along which migratory forces impact the implantable medical device (Shank’086 and Ben-Muvhar’169 teach the anti-migration member is oriented in the same direction as applicant’s invention).
Claim 15: Ben-Muvhar’169 teaches the lumen apposing stent (Figure 7b) further comprises:
a proximal retention member (flared portion on the left side of Figure 7b; labeled as 202 in Figure 2) along the proximal end of the elongate body;
a distal retention member (flared portion on the right side of Figure 7b; labeled as 200 in Figure 2) along the distal end of the elongate body;
a saddle region (central, narrow region in Figure 7b; labeled as 204 in Figure 2) defined between the proximal retention member and the distal retention member (Figure 7b); and
the anti-migration member (1202 or 1204) extends from the retention members towards the saddle region (Figure 7b).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Muvhar’169 in view of Shank’086, as applied to claim 1, further in view of Gray et al. (US Patent Publication 2018/0361127).
Claim 10: Ben-Muvhar’169 teaches the proximal retention member (202) and the distal retention member (204) is formed from woven filaments (paragraph [0140]). The anti-migration feature (1202, 1204) is formed from an extension of the device (Figure 7b).
Ben-Muvhar’169 does not explicitly show the anti-migration feature is formed from an extension of the woven device.
Gray’127 teaches a similar device (100) that is woven (paragraph [0026]) and has anti-migration features (132, 142). Gray’127 teaches the anti-migration feature can be attached to the device or formed as extensions of the woven filament (paragraph [0026]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Ben-Muvhar’169 in view of Shank’086, such that the anti-migration features are extensions of the woven device, as taught by Gray’127, because this is a known method of manufacturing the device. One of ordinary skill in the art would be motivated to choose forming the anti-migration features as extensions of the woven device to create a single unitary product that is safer for implantation in the body because parts of the implant are less likely to break off when the implant is a single unitary device with no connectors.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 3 September 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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